The following data is part of a premarket notification filed by Tgm Medical, Inc. with the FDA for Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / Rlp, Uncoated; Tibial Insert / Baseplate....
| Device ID | K112285 |
| 510k Number | K112285 |
| Device Name: | MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE... |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | TGM MEDICAL, INC. 5145 Golden Foothill Parkway Suite 175 & 180 El Dorado Hills, CA 95762 |
| Contact | Dennis H Crane |
| Correspondent | Dennis H Crane TGM MEDICAL, INC. 5145 Golden Foothill Parkway Suite 175 & 180 El Dorado Hills, CA 95762 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-09 |
| Decision Date | 2011-11-04 |
| Summary: | summary |